The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome

Hypercholesterolaemia Clinical Trial

Official title:

The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065180
• Other study ID #: verhoevenhermans
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2014
• Last updated: May 19, 2014
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• metabolic syndrome according to ATPIII criteria 3 of the following:

• waist circumference >88cm (in females) or >102cm (in males)

• triglycerides >150mg/dl

• HDL <40 (50)mg/dl in males (females)

• blood pressure>130/85 or treatment for AHT

• glucose >110mg/dl

Exclusion Criteria:

• pregnancy

• treatment with cholesterol lowering drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolaemia
• Hypercholesterolemia

Intervention

Dietary Supplement:
• commercially available nutrition supplement
the food supplement contains red rice yeast and olive extract
• placebo

Locations

Country	Name	City	State
Belgium	University of Antwerp	Antwerp	Belgie

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL level		2 months	No
Primary	total cholesterol level		2 months	No
Primary	triglyceride level		2 months	No
Primary	HDL level		2 months	No
Secondary	OxLDL		2 months	No
Secondary	BMI		2 months	No
Secondary	malondialdehyde (MDA)		2 months	No
Secondary	8-OH-deoxyguanosine (8-OHdG)		2 months	No
Secondary	side effects		2 months	No
Secondary	waist circumference		2 months	No